Tranexamic Acid in Patients for Caesarian Delivery.

Not Applicable

Completed

• Conditions: Obstetric Anesthesia Problems; Postpartum Hemorrhage; Cesarean Section Complications
• Interventions: Drug: Tranexamic acid injection

• Registration Number: NCT05759156
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Study Start: 2023-03-20
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-01
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 572

Inclusion Criteria

The inclusion criteria will include:

1. Informed consent of the participant
2. All women who are 18 years old or above
3. Gestational age equal or above 34 weeks
4. Women undergoing emergency or elective CD
5. Complete blood count (CBC) within seven days before the CD

Exclusion Criteria

The exclusion criteria will include:

1. Women with thromboembolic or bleeding incidents in the past
2. Hypersensitivity to TXA
3. History of epilepsy or seizure
4. Women with abnormal placenta including accreta, increta or percreta
5. Any active cardiovascular, renal, or liver disorders
6. Autoimmune disorders
7. Sickle cell disease
8. Placenta Previa
9. Abruptio Placentae
10. Eclampsia or HELLP syndrome
11. Women who might undergo intraoperative complications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic acid injection	-
Normal Saline	Tranexamic acid injection	-

Primary Outcome Measures

Name	Time	Method
Occurrence of postpartum haemorrhage (PPH)	up to 2 days
Obstetrics quality of recovery (ObsQoR) score	at 2 days

Secondary Outcome Measures

Name	Time	Method
Measurement of postpartum blood loss	at 2 days
Frequency of emergency surgery for postpartum haemorrhage	up to 12 hours
Length of hospital stay	up to 4 days
Rate of ICU transfer	up to 1 day
Operative time	up to 3 hours
Rate of Maternal death	up to 3 months
Adverse events related to tranexamic acid	up to 3 months

Trial Locations

Locations (1)

DowUHS; 🇵🇰 Karachi, Sind, Pakistan